RESTRICTING COVERAGE WITH DESIGNED DELAYS FOR RIGOROUS EVALUATION

from Malcolm Maclure, Prof & BC Chair in Patient Safety, University of British Columbia

I have one suggestion based on experience in British Columbia: when restrictions on coverage must be implemented, use design delays (staggered implementation.)

Ideally these would be randomized control groups, but controlled time series designs, especially with matching, are almost as rigorous as RCTs in my experience, and institutionally they seem to be more feasible.

I was inspired by my interview with Tom Chalmers almost 20 years ago, to advocate within the British Columbia Ministry of Health for control groups to be used when the public drug plan (‘PharmaCare’) introduced restrictions on drug coverage. I call this approach ‘designed delays’ because delays are the norm, and ‘designed’ feels like adding orderliness to the process, whereas ‘randomized’ feels like adding chaos to a program that is already complex.

Chalmers told me he had urged the Veterans Health Administration to pair-match hospitals and randomly select one of each pair to be first with a new service while the other hospital was delayed as a control. Despite his close connections with the VHA, he thrice failed to convince the VHA to use designed delays — for Coronary Care Units, for CAT scans and for MRIs. He was very frustrated by the experience and stymied on how to routinize randomization.

In British Columbia, we now routinely implement prescribing education initiatives with randomized delays but our success in using designed delays for changes in drug coverage has been much more limited. Our main success in using designed delays was in 1999 when we partially restricted coverage of nebulized medications. It went so smoothly that the method of designed delays was endorsed for 2 other drug restriction policies (but the restrictions were never introduced for other reasons.)

In contrast, designed delays when ADDING coverage of a new medication seems to be much more difficult. The hope (or hype) that the new drug will yield better outcomes, makes delays unacceptable. On the other hand, SUBTRACTING a medication or service that is believed by many (but not everyone) to be of little value, is made easier by promising rigorous evaluation by use of delays controls.

The most vehement critic and the strongest proponent of the policy AGREED that randomized delay was a good idea. They were both convinced that rigorous evaluation would prove they were right. Commitment to rigorous evaluation thus instantly refuted the criticism that the government was only interested in cost control, not patient outcomes.

A university ethics committee had no difficulty with randomized delays of the restriction because it eventually would apply to everyone, unless the evaluation showed the restriction was harmful (in which case the drug plan director was committed to reassessing the policy.) In contrast, another ethics committee was critical of our proposal for delayed coverage of a NEW medication.

My hypothesis is that when a health organization is forced to restrict services (e.g. the UK National Health Service must cut 20 billion pounds in the next four years), there will be many opportunities to evaluate the balance of benefits versus harms of the restrictions by using delayed controls.

Although Tom Chalmers’s advice mostly fell on deaf ears during times of plenty, I predict his advice will become more appealing to decision makers as cost pressures increase.

(These comments are my own opinions and observations in my academic capacity as Chair in Patient Safety at UBC. That appointment includes my continuation half-time as Co-Director of Research and Evidence Development, an advisory role in the Pharmaceutical Services Division of the BC Ministry of Health. I wish to stress that my opinions are not to be interpreted as representing the Ministry’s positions on these matters.)

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